GAITHERSBURG, Md., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Continuing its dedication to those patients impacted by rare diseases, today Sigma-Tau Pharmaceuticals, Inc. announced that it will expand its current patient assistance program to provide financial assistance for patients within the United States who are prescribed ADAGEN® (pegademase bovine)Injection for adenosine deaminase-severe combined immunodeficiency disease (ADA-SCID). The Company's new Co-Pay Assistance Program will cover all fees associated with co-pays incurred by eligible ADAGEN® patients. ADAGEN® is the only commercially approved enzyme replacement therapy available to treat ADA-SCID patients.

Commenting on the new program, Dave Lemus, Chief Operating Officer, Sigma-Tau Pharmaceuticals, Inc. said, "The health of our patients is the highest priority for Sigma-Tau, and we are very pleased to be able to offer this new assistance plan. Augmenting our existing compassionate use patient assistance program with this new plan, means no eligible ADA-SCID patient shall have to delay or forego treatment with ADAGEN® because of financial need."

The new ADAGEN® Co-Pay Assistance Program will cover 100 percent of any out-of-pocket costs associated with the purchase of ADAGEN®, such as co-payments, co-insurance, and deductibles for eligible patients currently covered under private insurance. Those patients without insurance may also receive ADAGEN® through Sigma-Tau's Compassionate Use Program. ADA-SCID patients seeking assistance are encouraged to call 1-866-352-3229 to discuss the various coverage options provided by Sigma-Tau.

"ADAGEN® is an essential treatment for ADA-SCID patients. Without access to this therapy, a number of families impacted by ADA-SCID would be left without a disease management option," said Marcia Boyle, President and Founder, Immune Deficiency Foundation. "Sigma-Tau is to be commended, not only for investing in a vital therapy for an extremely rare population, but also for recognizing that some patients and families will need co-pay assistance for this therapy."

Sigma-Tau's new ADAGEN® Co-Pay Assistance Program is one of several plans that the company has in place for providing assistance to people with rare diseases. Other programs include the Sigma-Tau Outreach Service (S.O.S), which assists eligible patients in accessing ONCASPAR® (pegaspargase), Carnitor® (levocarnitine), and DepoCyt® (cytarabine liposome injection), among others.

About ADA-SCID

Severe combined immunodeficiency disease (SCID) is a primary immune deficiency caused by several different genetic defects in the immune system. The syndrome is "severe" because it can be fatal by 2 years of age and "combined" because it involves both cell-mediated (T lymphocytes) and humoral (B lymphocytes) immunity. There are at least 15 known genetic causes of SCID, one of which is caused by a deficiency of the enzyme adenosine deaminase (ADA) and is known as ADA-SCID.

About ADAGEN®

ADAGEN® (pegademase bovine) Injection is indicated for enzyme replacement therapy for adenosine deaminase (ADA) deficiency in patients with severe combined immunodeficiency disease (SCID) who are not suitable candidates for – or who have failed – bone marrow transplantation.

Important Safety Information

ADAGEN® (pegademase bovine) Injection is recommended for use in infants from birth or in children of any age at the time of diagnosis. ADAGEN® (pegademase bovine) Injection is not intended as a replacement for HLA identical bone marrow transplant therapy. ADAGEN® (pegademase bovine) Injection is also not intended to replace continued close medical supervision and the initiation of appropriate diagnostic tests and therapy (e.g., antibiotics, nutrition, oxygen, gammaglobulin) as indicated for intercurrent illnesses.

There is no evidence to support the safety and efficacy of ADAGEN® as preparatory or support therapy for bone marrow transplantation. Since ADAGEN® is administered by intramuscular injection, it should be used with caution in patients with thrombocytopenia and should not be used if thrombocytopenia is severe.

The optimal dosage and schedule of administration should be established for each patient. Plasma ADA activity and red cell dATP should be determined prior to treatment. The treatment of SCID associated with ADA deficiency with ADAGEN® should be monitored by measuring plasma ADA activity and red blood cell dATP levels.

The following adverse reactions were reported during clinical trials: headache in one patient and pain at the injection site in two patients.

Sigma-Tau Pharmaceuticals, Inc. is a U.S. based, wholly owned subsidiary of the sigma-tau Group, and is dedicated to the global development and commercialization of medicines for patients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland. Since 1989, the company's products have been focused on rare diseases, including kidney disease, certain genetic disorders and cancers. With more than 7,000 identified rare diseases that affect approximately 30 million patients in the United States, Sigma-Tau places its considerable scientific resources behind the development and commercialization of compounds that benefit the few. The company has a substantial development program focused on transplant, cancer, inherited genetic disorders, malaria, and other areas of unmet medical need. For more information about the company, visit www.sigmatau.com.

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